Avaxim 80 is commonly used to help achieve protection against the Hepatitis A virus (HAV) infection. Its primary function is to prevent illness in the target pediatric population (12 months to 15 years), and its use is considered relevant for the prevention of infection induced by hepatitis A virus.

Prevention of Acute Hepatitis A and Serious Liver Pathology

The primary therapeutic domain is the prevention of the acute disease, which supports the avoidance of serious liver pathology associated with HAV. This application may assist with reducing the likelihood of developing the full syndrome of illness. The core patient benefit is relevant for easing the overall symptom burden, which contributes to improved comfort during periods where symptoms might interfere with daily functioning.

Avoidance of Severe Systemic and Hepatic Symptoms

Avaxim 80 helps address symptom clusters that may otherwise lead to symptoms related to systemic imbalance and symptoms linked to organ-specific functional stress, such as fever, fatigue, malaise, jaundice, nausea, and abdominal discomfort. This is why the vaccine is commonly used across conditions presenting with acute episodes where the patient faces increased risk.

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Quick Fact: Relief for Acute Systemic Viral Distress

Avaxim 80 supports the patient by helping to ease distress and assists with maintaining functional stability when symptoms become more noticeable due to viral exposure.

Regulatory References

1. BPOM therapeutic guidance

Eligibility Profile

The use of Avaxim 80 is strictly defined by regulatory eligibility criteria regarding age, hypersensitivity, and current health status.

Who Can Use Avaxim 80

The vaccine is indicated for active immunization against Hepatitis A infection in children aged from 12 months up to and including 15 years. Safety and efficacy are not established for children under the age of 12 months. Use is generally possible during breastfeeding.

Who Must Not Use Avaxim 80 (Contraindications)

Avaxim 80 must not be used in individuals with a known severe allergy (hypersensitivity) to the active substance, to any of the excipients used in the formulation, or to neomycin (which may be present in trace amounts due to the manufacturing process). It is also contraindicated if an individual has experienced a hypersensitivity reaction after a previous dose of this vaccine.

Use Requires Caution or Postponement

Condition	Eligibility Status	Special Consideration
Acute Febrile Illness	Postponed	Vaccination must be delayed until recovery from a severe acute illness.
Impaired Immunity	Conditional	The immune response may be diminished by immunosuppressive treatment or immunodeficiency.
Pregnancy	Not Recommended	Use is generally discouraged as a precaution due to inadequate human data, unless there is a major contamination risk.
Phenylketonuria (PKU)	Conditional	Caution is advised due to the presence of phenylalanine in the formulation.

Interactions with other medicines and products

Interactions involving Avaxim 80, an inactivated vaccine, are primarily defined by its effects on the immune system and mandatory administration rules, rather than the metabolic interactions typical of small-molecule drugs. All documented interaction information is derived from official regulatory labeling.

Documented Pharmacodynamic and Procedural Interactions

Interaction Type	Officially Documented Constraint
Immunological Suppression	Co-administration with immunosuppressive treatments (including corticosteroids and cytotoxic drugs) or pre-existing immunodeficiency states may impair the immune response to the vaccine.
Physical Incompatibility	Must not be mixed with other vaccines or medicinal products in the same syringe due to physical incompatibility.
Administration Timing	If administered concomitantly with other vaccines or immunoglobulins, separate syringes and separate injection sites must be used.
Antibody Response	Concomitant administration of immunoglobulins may result in lower antibody titres than the vaccine administered alone, though seroprotection rates are often reported as unaffected.

Official regulatory documentation notes that the immune response may be limited in subjects with chronic immunodeficiency. No specific interactions are documented in regulatory sources regarding common metabolic pathways, drug transporters, or with food, alcohol, or herbal products.

Avaxim 80 functions as an active immunizing agent by introducing a formalin-inactivated preparation of the Hepatitis A virus (HAV) GBM strain, adsorbed onto aluminum hydroxide. The aluminum compound acts as an adjuvant, enhancing the immune response by promoting the retention and presentation of the viral antigen at the injection site, facilitating interaction with antigen-presenting cells (APCs), such as dendritic cells and macrophages.

Following intramuscular administration, APCs internalize the inactivated HAV virions and migrate to regional lymph nodes. Here, the processed viral antigens are presented via MHC Class II molecules to CD4+ T helper cells. This specific T-cell receptor engagement triggers a downstream cytokine cascade that activates B-lymphocytes. Activated B-cells differentiate into plasma cells and memory B-cells.

The system-level physiological consequence is the robust and durable humoral immune response, characterized by the production of anti-HAV antibodies (principally IgG). These circulating antibodies serve as the primary biological effector by specifically targeting and neutralizing the Hepatitis A virus upon subsequent exposure, preventing viral replication within host cells.

Official Administration Instructions for Avaxim 80

Avaxim 80 is an inactivated Hepatitis A vaccine administered by a healthcare professional following a two-dose schedule to confer long-term protection in adults and adolescents aged 16 years and above.

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Dosing and Route

Scope	Details
Age Group	Adults and adolescents from 16 years of age.
Route of Administration	Intramuscular (IM) injection.
Dose Volume	A single dose of 0.5 ml (160 ELISA units) per injection.
Primary Vaccination	Consists of a single 0.5 ml dose.
Booster Dose	A second dose is recommended between 6 and 12 months after the primary dose to provide long-term protection, and may be administered up to 36 months later.

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Procedural Requirements

1. Preparation: The vaccine suspension is a cloudy, whitish liquid. The syringe must be shaken well immediately before injection to ensure a homogeneous suspension. It should also be visually inspected for any abnormal physical appearance or particulate matter.
2. Injection Site: The recommended site for intramuscular injection is the deltoid region (upper arm muscle).
3. Prohibitions: The vaccine must not be administered via the intravenous (IV) or intradermal routes. It is also not recommended to inject into the buttocks, as this may reduce effectiveness.
4. Special Conditions: In exceptional cases, such as in individuals with thrombocytopenia (low platelet count) or other bleeding risks, the vaccine may be administered by the subcutaneous route instead of intramuscularly.

Research Evidence / Overview of Studies for Avaxim 80

Evidence for Active Immunization Against Hepatitis A in Children (Ages 12 Months to 15 Years)

Research exploring the effects of Avaxim 80 primarily consisted of randomized controlled trials (RCTs) and open-label studies. These studies were focused on measuring the development of anti-HAV antibodies, which is a measured response in studies of the vaccine. Researchers examined the seroconversion rate—the percentage of children achieving a certain protective antibody level—at specific time points after the single primary dose and a subsequent booster dose.

Studies reported measurements describing the percentage of participants who achieved or exceeded the anti-HAV antibody threshold within 1 month after receiving the first dose. Further research examined the administration of a booster dose. Research describes how the booster dose related to the monitoring of reported antibody levels in those children. It is important to note that the primary evidence comes from measured outcomes like antibody levels. Direct clinical trials focusing on the prevention of actual Hepatitis A disease—outcomes related to physical discomfort or functional limitations—are not well characterized.

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Long-Term Protection and Follow-up Studies

Research has explored the longevity of the antibody response following the full vaccination schedule (primary dose plus booster). Observational studies and extended follow-up cohorts monitored the persistence of anti-HAV antibody concentrations over defined time intervals extending up to 14 to 15 years in some groups. Modeling studies have also been used to provide predictions regarding the potential duration of antibody persistence, with some research providing estimates up to 30 years. However, long-term effects on clinical outcomes are not fully established.

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What is Still Uncertain About the Research for Avaxim 80

Despite the studies conducted, several limitations exist. Direct evidence from large-scale studies proving the prevention of Hepatitis A disease is limited, and findings are often inferred. Additionally, research is limited when it comes to children who have underlying health issues, such as severe chronic liver disease, or those who are immunocompromised. Studies exploring administration immediately after a potential exposure to the virus (during the incubation period)—are not well studied.

Common questions about Avaxim 80 (FAQ)

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Q: How long does the protection from Avaxim 80 typically last?

A: Studies and official information indicate that after receiving the full two-dose primary course, the protective anti-HAV antibodies persist for an extended period. Researchers have monitored these antibody levels for up to 14–15 years. Based on mathematical modeling, protection is predicted to last at least 30 years in a high percentage of recipients.

Q: Is Avaxim 80 the same as other vaccines for the same condition?

A: Avaxim 80 is a Hepatitis A vaccine containing a specific antigen strain (GBM) that has been inactivated. While its primary goal is the same as other Hepatitis A vaccines, it has a specific antigen quantity and is generally intended for a particular age group. Official documents do indicate it can sometimes be used as a booster dose following primary vaccination with certain other inactivated Hepatitis A vaccines.

Q: How quickly does Avaxim 80 start to work after administration?

A: Clinical trial summaries report that the vaccine successfully produces an immune response early on. The development of protective anti-HAV antibody levels is typically demonstrated within two weeks following administration of the first dose in over 95% of the individuals studied.

Q: What are the differences between Avaxim 80 and Avaxim 160?

A: The primary difference lies in the quantity of the active antigen. Avaxim 80 contains 80 ELISA units (EU) of the antigen and is generally intended for children and adolescents up to 15 years of age. Avaxim 160 contains 160 EU and is indicated for use in adults and adolescents aged 16 years and above.

Q: Are there studies about Avaxim 80 use in very old adults?

A: Avaxim 80 U Pediatric is not recommended for persons 16 years of age and older. The adult formulation, Avaxim 160 U, is indicated for all persons 16 years of age and above, which includes the older adult population. Specific studies focusing only on the 'very old' may not be summarized in general official labeling, as they are included in the broader adult group.

Q: Why is the number '80' included in the drug name Avaxim 80?

A: The number '80' in Avaxim 80 refers to the precise quantity of the active ingredient, the inactivated Hepatitis A virus antigen, measured as 80 ELISA units (EU) per dose. This unit measurement defines the concentration of the vaccine.

Q: What is still uncertain about the research for Avaxim 80?

A: Official information notes several limitations in the available research. These include limited direct clinical trial data on the prevention of actual disease, and limited data on the vaccine's use in children with underlying health issues or those who are immunocompromised. The effect of administration immediately after potential exposure is also not fully documented.

Q: Can I get other vaccines at the same time as Avaxim 80?

A: Official documentation indicates that Avaxim 80 may be administered at the same time as several routine childhood booster vaccines, such as those against diphtheria, tetanus, pertussis, or MMR. When multiple vaccines are given concomitantly, a separate syringe and a different injection site must be used for each product.

Q: Why are there different concentrations of the Avaxim vaccine available?

A: Different concentrations, such as the 80 U and 160 U formulations, are available to ensure the appropriate antigen dose is administered according to the recipient’s age. This allows the dose to be tailored to the specific immune needs of the pediatric versus the adult population.

Q: Can people with certain allergies still get Avaxim 80?

A: The vaccine is contraindicated (should not be given) to individuals with a known severe allergy to the active substance, any of the excipients (inactive ingredients), or neomycin (which may be present in trace amounts). Official product information does not typically list general food allergies, such as egg allergy, as a contraindication unless an excipient is involved.

Q: What evidence exists regarding the effectiveness of Avaxim 80 in children?

A: Clinical trials of Avaxim 80 in children aged 12 months to 15 years have reported that the vaccine is immunogenic, meaning it successfully prompts an immune response. Published studies suggest that protective efficacy against the disease itself has been reported to be greater than 90% in susceptible individuals.

Q: What level of protection does Avaxim 80 offer against different strains of the virus?

A: The vaccine contains the antigen from the Hepatitis A virus GBM strain. Hepatitis A virus has only one known serotype (or strain type), meaning that the vaccine’s induced protection is generally considered broad against known circulating strains of the virus.

Q: What are the main findings from the clinical trials for Avaxim 80?

A: Main clinical findings reported in official documents include that protective antibody levels (seroprotection) are typically achieved within two weeks after the first dose in over 95% of participants. The full two-dose schedule results in long-lasting antibody persistence, predicted to last at least 30 years in most individuals.

Q: What information is available about receiving Avaxim 80 while breastfeeding?

A: Official regulatory information specifies that Avaxim 80 may be used during lactation (breastfeeding). Official information indicates that use during lactation is permitted.

Q: Is Avaxim 80 safe for someone who is planning to travel internationally?

A: The vaccine is indicated for active immunization against the Hepatitis A virus. Official recommendations frequently include vaccination for individuals who may be at an increased risk of infection, such as those traveling to areas where Hepatitis A is endemic (common).

Q: What happens if I receive Avaxim 80 later than the recommended time frame?

A: While the booster dose is recommended between 6 and 12 months, the administration may still be possible up to 36 months later (and up to 7 years in some pediatric indications). Interrupting the schedule is not ideal, but regulatory evidence suggests a delayed second dose can still successfully boost the immune response.

Q: Can Avaxim 80 be administered to people with a weakened immune system?

A: Individuals with a compromised or weakened immune system, including those on immunosuppressive treatments, may receive the vaccine. However, the resulting immune response may be diminished and may not protect them as well as it protects those with a normal immune system.

Q: If I feel unwell on the day of my appointment, should I still get Avaxim 80?

A: Official instructions state that vaccination should be postponed in cases of a severe acute febrile illness (a severe illness with a high temperature) until the individual has recovered. Minor infections, such as a cold without a high temperature, do not typically require postponement.

Q: Why do some people need two doses of Avaxim 80 and others only one?

A: The required schedule involves a primary vaccination (one dose) to provide initial protection against the virus. A second dose, often referred to as a booster, is recommended later to ensure the establishment of a robust and long-lasting antibody level that provides protection for many years.

How to Store and Dispose of Avaxim 80

The storage and disposal of Avaxim 80 U Pediatric (Hepatitis A vaccine) must adhere to specific regulatory conditions to maintain its efficacy.

Storage Requirements

The vaccine must be stored in a refrigerator at a temperature between 2^circC and 8^circC. It is a mandatory requirement that the product must not be frozen; if freezing occurs, the vaccine must be discarded. To ensure stability, Avaxim 80 must be stored in its original package to protect from light and must be kept out of the reach and sight of children. Use is prohibited after the expiry date indicated on the packaging or if the suspension shows discolouration or foreign particles.

Official Disposal Rules

Medicines should not be disposed of via household waste or wastewater. Any unused product or waste material must be discarded in accordance with local requirements. Individuals should ask a pharmacist for guidance on how to properly dispose of medicines no longer required.